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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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370 records meeting your search criteria returned- Product Code: KRA Patient Problem: No Consequences Or Impact To Patient Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM 08/10/2020
BOSTON SCIENTIFIC CORPORATION DIREXION FATHOM-16 SYSTEM 08/10/2020
BOSTON SCIENTIFIC CORPORATION DIREXION TRANSEND-14 SYSTEM 08/07/2020
BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO 08/07/2020
BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI 08/04/2020
MEDOS INTERNATIONAL SARL PROWLER-14 DUAL MARKER 07/29/2020
BOSTON SCIENTIFIC CORPORATION DIREXION 07/28/2020
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO 07/27/2020
COOK INC CXI SUPPORT CATHETER 07/24/2020
EKOS CORPORATION EKOSONIC KIT 135CM 50CM TZ 07/23/2020
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